Supportive Care Mobile Application for Patients With NSCLC
- Conditions
- Non Small Cell Lung CancerCoping SkillsQuality of Life
- Registration Number
- NCT04629300
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.
- Detailed Description
This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.
The research study procedures include:
* A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
* Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
* Data collection from participants medical records
After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:
* Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
* Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.
Participants will be in this research study for 12-14 weeks.
It is expected that about 120 people will take part in this research study.
The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age >18 years
- Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
- Eastern Cooperative Oncology Group Performance Status = 0-3
- Plan to receive oncology care at one of the participating study sites
- Ability to read and respond to questions in English
- Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Study feasibility based on rates of participant recruitment and completion of assigned study procedures 12 weeks Study feasibility will be defined as ≥ 65% approach-to-enrollment rate of eligible participants and
≥70% completion rate of study procedures (at least four mobile app modules and assigned study questionnaires)
- Secondary Outcome Measures
Name Time Method Compare patient-reported coping between study groups on the Brief COPE Scale 12 weeks Compare between study groups patient-reported coping strategies based on scores from the Brief COPE Scale at 12 weeks (score range: 2-8 on each of 14 coping sub-scales; higher scores indicate greater use of that specific coping strategy)
Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale 12 weeks Compare between study groups patient-reported quality of life based on scores from the Functional Assessment Cancer Therapy-Lung Scale at 12 weeks (score range: 0-136; higher scores indicate better quality of life)
Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale 12 weeks Compare between study groups patient-reported anxiety and depression symptoms based on scores from the Hospital Anxiety and Depression Scale at 12 weeks (score range: 0-21 on the anxiety and depression sub-scales; higher scores indicate worse psychological distress)
Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale 12 weeks Describe patient-reported acceptability and ease of use of the mobile application intervention based on scores from the System Usability Scale (score range: 0-100; higher scores indicate greater acceptability and ease of use)
Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory 12 weeks Compare between study groups patient-reported symptom severity and interference based on scores from the MD Anderson Symptom Inventory at 12 weeks (score range: 0-10 on the symptom severity and interference sub-scales; higher scores indicate worse symptoms)
Trial Locations
- Locations (6)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mass General/North Shore Cancer Center
🇺🇸Danvers, Massachusetts, United States
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
🇺🇸Milford, Massachusetts, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Dana-Farber Brigham Cancer Center at South Shore
🇺🇸South Weymouth, Massachusetts, United States
Massachusetts General Hospital Cancer Center🇺🇸Boston, Massachusetts, United States